Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

November 30, 2007

Free speech suit dropped; Ex-sergeant at air base spoke out about vaccines

http://www.newszap.com/articles/2007/11/30/dm/sussex_county/dsn01.txt

By Randall Chase, Associated Press

DOVER — Attorneys for the Department of Defense and a former Air Force sergeant have agreed to dismiss a free speech lawsuit alleging that the airman was unfairly reprimanded for criticizing the military’s anthrax vaccine.

In a settlement reached Thursday, the Pentagon said a letter of reprimand given to Staff Sgt. Jason Adkins after he challenged the mandatory vaccination program in 2004was “deemed to be of no effect,” said Adkins’ attorney, Thomas Neuberger.

Neuberger said Adkins, who now works in the landscaping business, was elated with the outcome.

“The case was all about removing the adverse letter of reprimand from his file,” Neuberger said Friday. “We got exactly what we asked for.”

Officials with the Department of Defense and Justice Department had no immediate comment.

In May 2003, Adkins served on the first C-5 aircraft flown into Baghdad in the Iraq war.

Eight months later, he was one of 12 airmen who were deployed to Baghdad to fly a C-5Galaxy assigned to Travis Air Force Base in California that had been struck by enemy fire in Iraq.

In a lawsuit filed in November 2004, Adkins alleged that he was improperly disciplined by his superiors at Dover Air Force Base after seeking treatment for headaches and other medical problems he believed were related to the anthrax vaccine.

Adkins, 35, said he was grounded and received a letter of reprimand after discussing his suspicions about the vaccine with a Dover flight surgeon.

Adkins, a flight engineer and 14-year veteran, claimed that the Pentagon had used military personnel at Dover as guinea pigs for an experimental vaccine that contained squalene, an additive to boost its effectiveness.

Several other Dover airmen have made similar accusations, but military officials maintain that the vaccine is safe.

Critics believe that squalene, found in 1999 in small amounts in at least four vaccine lots from which doses were shipped to Dover and other installations, was responsible for mysterious ailments among some of those who received the vaccine.

A federal judge denied repeated requests by attorneys for former defense secretary Donald Rumsfeld and Air Force officials to have Adkins’ lawsuit dismissed.

“The lawsuit alleged that on orders from the highest levels of the Pentagon, the Air Force sought to make an example out of Sgt. Adkins to silence dissent in his squadron and ensure that military personnel would immediately cease questioning the safety of the tainted vaccine being administered at the Dover base,” Neuberger said in a press release.

After a federal judge in Washington determined in 2004 that the FDA’s approval process for the vaccine was flawed and issued an injunction against its mandatory use, the Pentagon switched to voluntary use.

The FDA subsequently affirmed its finding that the vaccine was safe, and the Pentagon announced last year that mandatory vaccinations would resume, prompting a lawsuit by service members.

November 29, 2007

Staying Army Strong

Junior Nicole Lillis' disdain for the U.S. Army and the government that controls it all comes down to a preventative measure that many in the United States and throughout the world take for granted nowadays.

It all comes down to a technological advancement that helps children ward off the flu and chicken pox.

It all comes down to a series of elixirs intended to protect soldiers in the event of a biological weapon - vaccines.

"I'm not going to tell you the fluffy story of the military," she often tells people when they ask her about her time in the service.

Lillis suffers from painful symptoms that are typically associated with autoimmune disorders. Lillis said she and doctors believe the vaccines the Army gave her to take at the beginning of her military career caused her immune system to become hyperactive.

Leading researchers agree and have shown a link between military vaccines and autoimmune disorders, claims and connections that the U.S. government emphatically denies.

Basic training

Lillis, 29, began her college education at UW-Eau Claire in 1998 as a criminal justice major. In January 2001, she decided to join the military, something she said she knew she wanted do since she was 16.

"I really wanted to see the world and travel," she said. "Everyone has their own reasons for joining. Some do it for money; some really want to do it. I just wanted to do it."

In high school, Lillis wanted to join the Air Force, but instead chose the Army, initially enlisting in the Airborne program, where she could "jump out of a perfectly good airplane."

She began her military service by reporting to Fort Leonard Wood, Mo., for basic training.

She said she remembers getting onto trucks and traveling to the Military Entrance Processing Station, which prepared her and the rest of the incoming recruits for the weeks ahead. There, soldiers got haircuts, purchased toiletries and got medical examinations, which included receiving the vaccines. Lillis said she and the other soldiers received 12 vaccines that day, one of which was experimental.

She said the soldiers then got back on to the trucks and went to their basic training units where the "drill sergeants were lined up waiting."

The sergeants screamed at the soldiers the moment the soldiers stepped off the trucks, she said, immediately making the recruits "get down and push."

Two months into the program, the symptoms began, she said. She began having extreme pain in her pelvis and joints, but kept telling herself that it was just the training catching up with her and that she wasn't going to be one of those who didn't finish.

After eight weeks of the physical gauntlet and excruciating pain, Lillis graduated from basic training. Immediately after she began training to be a military police officer.

"When you're going through it you're like, 'this is hell,'" she said. "But basic training was a riot. When you're done, you look back and say to yourself, 'I did that.'"

Once the programs were complete, she said the drill sergeants acknowledged the soldiers' hard work and gave them all advice.

Despite the stress fracture in her pelvis keeping her from heading to Fort Benning, Ga., for airborne training, one drill sergeant told her not to not pursue the training for other reasons.

"My drill sergeant looked me in the eye and said, 'The Army will never be worth your health,'" she said. "I will never forget that."

Pain continues

The completion of basic training and military police training was bittersweet for Lillis whose complications got worse shortly after finishing the programs.

She went to a civilian physician who was unable to find anything wrong with her body.

"I remember being so tired and in so much pain, but I just figured that it all had to do with the physical demand of basic training," she said. "So, I just pushed through it."

Lillis reported to Fort Hood, Texas, in June 2001 for her duty assignment where she worked for some time as a patrol officer and then moved to being a 911 dispatcher. There, she said her unit gave her a lot of flak for not being able to run like them due to the extreme pain she was in.

One night while at Fort Hood, Lillis said she woke up to go to the restroom when she collapsed onto the floor and vomited continually. A doctor at the military hospital examined her and diagnosed her with bursitis, joint inflammation and gave her high doses of ibuprofen for the pain.

Dead ends

Lillis said her pain worsened through her time at Fort Hood, and she continued receiving the same diagnosis each time doctors examined her at the military hospital and received the same treatment of ibuprofen and cortisone injections. One doctor went as far to give her Zoloft, an anti-depressant, even after Lillis repeatedly told the doctor she was not depressed.

Finally, a breakthrough came in January 2002 when the doctor diagnosed Lillis, 23, with fibromyalgia, a disease that causes severe muscle, joint and bone pain.

The diagnosis led to the military honorably discharging her in May 2003. She remained in Texas until January 2006, when she moved back to Wisconsin and began her own research into vaccines causing autoimmune disorders, which took her into diseases such as Gulf War Syndrome and lupus. This included research that Dr. Pamela Asa conducted, who discovered the connection between the anthrax vaccine and autoimmune disorders.

Lillis said insurance companies view soldiers as having a pre-existing condition, making them ineligible for affordable insurance after their time in the service. So the only affordable health care is through Veterans Affairs hospitals. Lillis initially went to the VA hospital in Tomah for treatment but said doctors attempted to treat "the symptoms and not the problem."

When she would ask doctors about the possibility of vaccines causing her ailments and noting the experimental one she received, the doctors would ignore the comment or deny it. She said one doctor even went as far as asking if she had an appointment with the psychiatric ward that day after she brought up the vaccine question.

Her luck changed when a Tomah VA doctor referred her to a doctor at the Madison VA hospital who, in the summer of 2006 told her she was on the borderline for lupus and that there was no doubt the vaccines "kicked her immune system into overdrive."

The vaccines

When Lillis and the other recruits rolled up their sleeves for vaccinations during basic training, they got stuck with 12 needles. Soldiers had to sign an informed consent document before receiving one of the vaccines. She said when soldiers asked why they needed to sign the form, the doctors and drill sergeants told them it was for a pneumonia vaccine.

"We were given the one page to sign without any information on it," she said, showing the piece of paper she signed that day. "The drill instructors screamed at us to sign the consent document and told us if we didn't, they would be sure our lives were a living hell. They intimidated us into signing it."

Under U.S. Code Title 10, Section 1107, when the Secretary of Defense requires or requests soldiers to take an experimental or non-Food and Drug Administration approved vaccine, the Department of Defense must inform the soldiers in writing of the purpose of the drug, the fact that it is investigative or unapproved and its potential side effects before they give it to them. The soldiers must also provide informed consent before receiving the vaccine.

Lillis later found three more pages to her consent form after reviewing her medical records after her time in the service. She said she never saw the pages before getting the vaccine.

The vaccine Lillis received was an investigative pneumonia vaccine that the Department of Defense said the elderly have used successfully for years, saying soldiers should not worry about taking it, according to the consent form. Lillis said she is skeptical if that was really what the vaccine was.

"If the elderly have been taking it for years and it has been effective, then why did we have to sign a consent document?" Lillis asked.

If Lillis or the other soldiers refused to sign the form and take the vaccine, they could have faced a court-martial or a dishonorable discharge for refusing a direct order, according to the Army handbook.

Connections are made

In 1994, Asa, an immunologist, said the path to discovering the connection between vaccines and autoimmune disorders started when Gulf War veterans came to her with rashes, severe pain, headaches and memory lapses.

"It sounded like these people had lupus," Asa said. "This was uncommon because most of them were men," noting lupus typically affects women.

Soldiers who served in the United States during the war were experiencing the same symptoms as those serving abroad, so Asa looked to determine what both groups had in common. She said she thought the answer lay in vaccines.

"I said to myself, 'Oh my God, somebody spiked the punch with an adjuvant," she said, explaining that adjuvants are added to vaccines to increase their effectiveness.

The daunting task of determining what the adjuvant was and what vaccine it was in began.

Asa had help from a former colleague at Tulane University in Louisiana, Dr. Bob Garry, a leading researcher in creating an AIDS vaccine, who developed a test that showed the presence of squalene, an oil-based adjuvant, in blood in 1997. The test detected anti-squalene antibodies.

She said she sent Garry blood samples from soldiers that came to her with symptoms to have him test for the anti-squalene antibodies.

She said initially the anthrax vaccine wasn't on the table until the mandatory Anthrax Vaccine Immunization Program started in 1998. Asa said that was when soldiers began coming to her with symptoms again.

They too tested positive for anti-squalene antibodies, she said.

The AVIP ran through June of 2001 when the Department of Defense temporarily stopped using the vaccine due to non-FDA-approved production methods, according to program records.

The program used Anthrax Vaccine Absorbed, which the FDA approved in the 1970s to protect against skin contact with anthrax spores, not inhalation as the military was using it during AVIP, according to the vaccine's history explained in a U.S. District Court opinion. The FDA eventually labeled the vaccine as an investigative experimental vaccine in the use against inhalation of anthrax spores, according to the opinion, which would place it under Title 10 Section 1107 of the U.S. Code.

Asa tracked the lot numbers of the vaccine, determining that six anthrax vaccine lots had some levels of squalene in them. Later, an independent FDA test confirmed these lot numbers.

"I can't put into words the look of horror on (the soldiers') faces and how difficult it was to tell them that the country and the government they were willing to die for had done this to them," Asa said. "It makes me sick to tell these kids they are positive for anti-squalene antibodies. I hope like hell they're negative."

Lillis said she isn't sure if she received the AVA during basic training because her immunization records were not with her medical records, however, AVIP was still in progress in January 2001.

Court steps in

Several soldiers took their cases to Congress and ultimately brought a lawsuit against the Department of Defense in the form of Doe v. Rumsfeld. As a result, the U.S. District Court issued a temporary injunction on AVIP on Dec. 22, 2003, according to AVIP policy records, which later became permanent in October of 2004, according to the court order.

In February 2007, the Department of Defense reinstituted mandatory anthrax vaccinations for soldiers. AVIP has inoculated nearly 1.8 million soldiers and defense workers since 1998, according to AVIP records.

Government reaction

Both Asa and Lillis said they, along with other soldiers affected by unknown sickness, have been trying to get the government to acknowledge the harm caused by vaccines, but both said they have gotten nowhere.

"I've been fighting this since 1994," Asa said. "I have been receiving hell for it the entire time."

She said certain officials in the government have accused her and Garry of having an anti-military agenda.

"We don't have an anti-military agenda," she said. "I got into this because I am indebted to military personnel who will take a bullet for one of my kids."

The government's reaction to Lillis has been the same to most soldiers experiencing problems, Asa said, noting the military would blame the symptoms on things other than the vaccines or would call the soldiers "crazy" and argued that they suffered from Post Traumatic Stress Disorder.

A representative from the Military Vaccine Agency, the Department of Defense body that oversees military vaccine policies, refused to give his name due to Department protocol. He said that protecting soldier health is the No. 1 priority of the agency and the Department and said that all vaccines administered are "safe and effective."

"Absolutely all of the vaccines are FDA approved," he said. "There have never been experimental vaccines given to any service members. All service members are given licensed, proven safe and effective vaccines that are approved by the FDA and are administered under the guidance of the American Council of Immune Practices."

Susan Walker, the Midwest regional analyst for the agency, as well as clinical and communication specialists within the agency, did not comment on questions asked of them.

Pressing forward

Lillis, now an organizational communications major, said her symptoms are ongoing six years later. She recalled an incident that happened during this summer in which she had a severe migraine and began vomiting continually - an event she has experienced in the past. She said the distance to the nearest VA hospital in Tomah, apart from the Chippewa Falls hospital which she said doesn't accept walk-in appointments, makes it very scary when she does get severely sick.

She said that the muscle, joint and bone pains have gotten worse, noting that at times her back and neck muscles spasm, causing migraines. She also said she started taking the prescribed muscle relaxants again, adding it is sometimes difficult for her to get out of bed in the morning.

Despite her complications Lillis said she doesn't let it get her down and said she has a support network of family and friends who help her through the struggles. She said she doesn't want people to feel sorry for her because she doesn't feel sorry for herself.

"It is just something that I live with," she said.

She said she doesn't regret the experiences of the Army. Although she said she would rather have her health, the events of the last six years have shaped her into the person she is today.

Lillis also said she won't give up the battle for people to acknowledge that what is happening to her is real.

"I don't let it get me down," she said. "I'm so stubborn and I will fight this until the end."

November 24, 2007

Vaccines Threaten Up to 44,000 U.S. Soldiers

A U.S. soldier in Iraq, Pfc. Leif Hamre, 22, may face dismissal for refusing the anthrax vaccine. According to his own statements, he’s already been given an Article 15 – a non-judicial military punishment – including being taken off missions, assigned 18-hour workdays, and reduction in his pay scale, in addition to being subjected to threats and intimidation.

Concerned about the questionable safety of the vaccine, he became even more concerned after he discovered the military wasn’t even handling the vaccine under the rules for storing it at the correct temperature.

In an open letter he states, “The tactics they have used to coerce me into taking the shot are unregulated, unscrupulous and downright un-American.”

But Hamre is not alone in his opposition to the vaccine. A recent report from the General Accounting Office (GAO) confirms that about one to two percent of immunized individuals may end up with severe adverse reactions, including disability, chronic disease and death. Even at that seemingly low risk, when calculated across the 2.2 million in the service, an estimated 44,000 enlisted could potentially end up in the morgue.

The vaccine BioThrax, manufactured by BioPort (now called Emergent Biosolutions) is the only FDA-licensed anthrax vaccine available in the U.S. However, even BioPort’s own insurance company, Evanston Insurance, has sued BioPort, alleging “material misrepresentations about incidents, conditions, circumstances, defects, or suspected defects in the vaccine.”

Says Leif Hamre, “… I am an American citizen too, with rights I thought we were fighting to protect. I have given two years of dedicated service to the Army, with a clean record and a willingness to sacrifice for my country and fellow soldiers… I just don’t think any of this seems right…”

Dr. Meryl Nass, a diplomat of the American Board of Internal Medicine, has a warning for all citizens in the U.S., stating that if there should be another anthrax attack, such as the powder-laced envelopes received at the U.S. Senate office in 2001, an order requiring mandatory inoculations of civilians is both legally and technically possible.

November 19, 2007

Emergent BioSolutions says HHS to continue buying Anthrax vaccine

HHS continues to throw money down the rabbit hole, and continues to put the public at risk with the anthrax vaccine.

http://www.abcmoney.co.uk/news/192007167797.htm

NEW YORK (Thomson Financial) - Emergent BioSolutions Inc. Monday said the Department of Health and Human Services plans to continue purchasing BioThrax, an anthrax vaccine, under the current contract for 18.75 million doses for a fixed price of $400 million.

The contract includes an additional $34 million upon receipt of regulatory approval of four-year dating.

'The HHS contract provides us with a baseline of revenue sufficient to support the growth and profitability of our company in 2008 and 2009, and we intend to expand our revenue sources, including with the Department of Defense,' the Rockville, Md.-based company said.

Shares of the immunobiotics-focused biopharmaceutical company were up by 3 cents at $5.10.

November 18, 2007

Soldier refuses anthrax vaccine

While serving in Iraq, Army Private First Class Leif Hamre of Prior Lake chose to take a stand against the mandatory anthrax vaccination the Army requires for soldiers in high-risk areas.

His stance fell upon deaf ears.

Upon entering the Army, Hamre, 22, was proud to serve his country and follow in the footsteps of his father, John, who was also a member of the U.S. Army, said Leif’s mother, Mary.

On June 24, Leif was given a document to complete prior to taking the mandatory anthrax vaccine. After receiving the form, Leif had 24 hours to decide whether to take the mandatory vaccine or face military punishment for disobeying a direct and lawful order from his commander.

Leif wrote in a letter to his parents that he spent hours doing “unbiased research” on his laptop computer that night when he came across information stating adverse reactions believed by some to be connected with the anthrax vaccine.

Some of the information Leif discovered included seizures, arthritis, migraines, heart attacks, blackouts, depressed behavior and death stemming from the vaccination.

After learning of the symptoms some veterans have faced, Leif decided to refuse the vaccine. In his letter, Leif wrote that he believes “the shot was dangerous and should still be in the lab for further testing.”

Before refusing the vaccine, Leif was an honorable soldier; he did his duties, didn’t make waves and was about to be promoted, Mary said.

After refusing the vaccination twice, Leif said he was punished with an Article 15, a non-judicial punishment for disciplinary offenses, which included a reduction in rank from specialist to private first class and working 18-hour days seven days a week for 15 days. After refusing the vaccine again in August, Leif wrote that he was taken off missions, demoted in rank from E-3 to E-1, decreased in pay and put on a 45-day restriction of extra duty.

Scott County Veterans Service Director Todd Kubinski said these punishments are a command-summary judgment (which doesn’t have to go through a jury) and are not unusual for a soldier facing an Article 15 punishment.

In addition to the dock in pay and rank and long work hours, Leif wrote that his commanders turned his platoon against him and threatened him in an attempt to get him to take the vaccine.

“The tactics they have used to coerce me into taking the shot are unregulated, unscrupulous and un-American,” Leif wrote. “As an American soldier you are expected to follow orders and put yourself in harm’s way, but unnecessary safety risks should not be accepted risks one is asked to face.”

But a soldier suspends the rights citizens have under the constitution while under military order, Kubinski said. When a soldier takes the oath, he or she swears to follow orders by officers, he said.

Kubinski said he hasn’t seen a case of claims concerning adverse reactions to the anthrax vaccination in his years working with Veterans Services in Hennepin or Scott counties.

“I don’t know if the vaccine is safe or not, but I know the vaccine has undergone a lot of testing by the military,” Kubinski said. “I do know if you are stationed somewhere you are required to take vaccinations and follow lawful orders. As for refusing to follow orders… it is my experience that you are required to follow orders or be punished by Article 15.”

When asked, U.S. Rep. John Kline’s office refused to comment on this issue.

An Army spokesperson, Maj. Nathan M. Banks Sr., said the vaccine has been controversial because of unproven myths. More than 20 studies of more than 800,000 vaccine recipients have established the safety of the vaccine, he said.

“We vaccinate our service members to protect them against deadly diseases – both natural and those potentially spread by terrorists or enemy forces,” Banks said.

The vaccine is used to prevent an anthrax infection and is the safest means of protection for high-risk personnel, Banks said.

All uniformed personnel, emergency-essential and equivalent Department of Defense civilian employees assigned for more than 15 days to U.S. Central Command or U.S. Forces in Korea are required to take the vaccine. There are also provisions for forces afloat, uniformed personnel assigned to special units and bio-warfare or bio-terrorism missions and other designated units must take the vaccine, Banks said.

Under the voluntary policy, only about half of service members in high-threat areas who were contacted about the vaccine volunteered to take it, Banks said.

“This low rate of vaccination not only put the service members at risk, but also jeopardized unit effectiveness and degraded medical readiness,” Banks said.

Historically, there have been few cases of insubordination in regards to taking the vaccine, Banks said.

“Most service members follow orders and understand that the vaccinations protect them and their units against a biological attack,” he said.

But the vaccine is a mandate that shouldn’t be in place, Mary Hamre said.

“Our government is abusing the privilege of ‘owning the soldiers,’” she said. “I have never heard of the soldiers being attacked with anthrax. We need to question the military’s reasons for the vaccine. We need to demand answers when soldiers are coming home sick from vaccines.”

“Soldiers are not supposed to say ‘no’ before the fact if they believe something is wrong,” John Hamre said. “If a soldier questions something, it’s supposed to be questioned after the fact. But then it’s too late.”

The proper procedure when disputing a military order is to go through the chain of command, Kubinski said. If there’s a problem, the soldiers must use a Judge Advocate General (JAG) lawyer or the inspector general, whose job is to see to the health and welfare of the troops.

Mary said Leif went to a JAG lawyer who advised him to take the vaccine or find someone else to represent him. But there isn’t anyone else until he is out of the service, she said.

The Food and Drug Administration issued a final ruling on Dec. 19, 2005, stating the anthrax vaccine is effective in preventing anthrax disease regardless of how soldiers may be exposed to it, Banks said. The licensed vaccine is safe and effective based on sound science by eight separate reviews, he said.

Dr. Meryl Nass, a physician from Maine who has treated service members who have become ill from the anthrax vaccine, disputes these claims.

Nass said there is no published evidence that the vaccine prevents any form of anthrax in humans. The 2002 Institute of Medicine committee did state this, but they had no evidence to prove it, she said. Five years later, there is still no evidence, she said.

Another point of contention regards the vaccine’s safety compared to other licensed vaccinations.

Banks said the “adverse events after anthrax immunizations are comparable to those observed with other vaccines administered to adults. There is no evidence that life-threatening or permanently disabling immediate onset adverse events occur at higher rates in individuals who have received the anthrax vaccine than in the general public.”

Nass also disputed this claim.

Nass said the anthrax vaccine has not been proven as safe as any other vaccine. The anthrax vaccine has the highest rate of reports of adverse reactions to the Vaccine Adverse Events Reporting System of any licensed vaccine in the United States, she said, citing the Center for Disease Control’s Morbidity and Mortality Weekly report.

Banks said based on 35 years of anthrax vaccine use, it has been documented that severe, but temporary, injection-site reactions can happen. He also said it’s known that 30 to 60 percent of people who receive the vaccine will develop a 1-inch injection-site reaction and about one in 100 people develop a reaction 5 inches or larger. The rate of side effects away from the site is about the same as other vaccines occurring in 5 to 35 percent of people, with effects going away in days, he said.

ProtectingOurGuardians.org claims that 21 deaths from the vaccine have been reported to the Food and Drug Administration since 2000 through the Vaccine Adverse Event Reporting System (VAERS). The group also claims that 5,120 people have reported adverse reactions to the anthrax vaccine to VAERS.

FDA spokesperson Peper Long said through May 5 2007, 25 deaths have been reported to VAERS following the anthrax vaccination.

“From the information submitted, none of the deaths reported to VAERS can be directly attributed to the vaccine, but in any individual report, we cannot definitively rule out that the vaccine played a role,” Long said.

VAERS is a collection of raw data, Long said. Reports can come from a variety of sources. It is a passive survey system in which data is used by the FDA and the Center for Disease Control to see trends, she said. There are situations where issues are over reported and definitely issues where issues are under reported, Long said. Each serious report is followed up by phone calls to acquire as much information as possible about the report, she said.

Though Leif’s stand has caused him a dock in pay, rank and possible general discharge status when he finishes his time in the Army, he has done this for his fellow soldiers, his mother said.

“I am very proud of Leif,” his father added. “It takes one heck of a guy to stand up to the military. I was in the service, and I don’t think I would have stood up to them.”

“Our job is hard,” Leif wrote in his letter. “The things many soldiers have to deal with [are] trying. Not only are we assaulted with mortars, rockets, roadside bombs and gunfire, but we must also accept harmful chemicals into our bodies. They don’t give us armored vehicles and ballistic vests for it; instead we have to trust the impeccable record of the government when it comes to exposing soldiers to harmful substances and denying any responsibility of the outcome.”

Leif Hamre left Iraq with his squadron on Nov. 17. He is currently stationed in Alaska to finish his time in the service. He will have a short vacation in December before heading back to Alaska. It is unclear what his discharge status will be when completing his military commitment.

Shawn Hogendorf can be reached at (952) 345-6374 or shogendorf@swpub.com.

November 17, 2007

University of New Mexico lab rabbit tests positive for anthrax

Comment from Dr. Nass (mnass@gwi.net):

*In the article below, a laboratory rabbit turned out to have anthrax. The spokesperson says don't worry; the anthrax is found naturally in the New Mexisco soil. How did the rabbit get anthrax from soil when it lives in a cage? Twenty people are to receive antibiotics. None are getting vaccine: why would they, since antibiotics are 100% effective for susceptible strains? -- Meryl

University of New Mexico lab rabbit tests positive for anthrax

Associated Press - November 17, 2007 12:54 PM ET

ALBUQUERQUE (AP) - Two people who performed a necropsy on a laboratory rabbit that has tested positive for anthrax have been given antibiotics as a precaution.

A team of epidemiologists and scientists are trying to determine how the rabbit used as part of a research project at the University of New Mexico was exposed to anthrax.

A spokesman for UNM's Health Sciences Center, Sam Giammo, says the incident is not a public health threat.

He says the anthrax found in the rabbit occurs naturally in the soil in New Mexico.

The state Department of Health announced yesterday that a tissue sample from the rabbit tested positive for anthrax, which can be passed from animal to human.

November 14, 2007

Ex-Walter Reed Chief to Command Biodefense Research

http://www.nti.org/d_newswire/issues/2007_11_14.html#7B73C5B5

The U.S. Army said yesterday it has reassigned the general fired from his leadership post at the Walter Reed Army Medical Center to supervise biological defense research at Fort Detrick in Maryland, the Associated Press reported (see GSN, Jan. 23).

Maj. Gen. George Weightman lost his job as head of the Army’s top hospital March 1 following a series of Washington Post reports that uncovered widespread neglect of wounded U.S. soldiers at the Washington, D.C. facility.

The Army said earlier this year that top officials “had lost trust and confidence” in Weightman’s leadership following the revelations of neglect.

However, Army spokesman Paul Boyce said that senior Army officials reconsidered their judgment of the two-star general when they examined his attempts to improve care for soldiers, veterans and families at Walter Reed and at the Army surgeon general’s office in Falls Church, Va., where he currently works as a physician.Weightman is expected before the end of November to take charge of Fort Detrick and of the U.S. Army Medical Research and Materiel Command, which operates at the Frederick, Md., installation.

It was a widespread assumption that being fired from Walter Reed would bar Weightman from assuming another high-level post, said Paul Rieckhoff, executive director of Iran and Afghanistan Veterans of America.

“The way Walter Reed turned out should be a career killer,” he said. “If Weightman's getting a second chance here, I think the Army needs to explain why the turnaround happened” (David Dishneau, Associated Press/International Herald Tribune, Nov. 14).

Emergent BioSolutions Inc. (NYSE: EBS) has been advised that the U.S. Department of Defense intends to pursue a collaborative arrangement with the U.S. Department of Health and Human Services to facilitate the use by DoD of stockpiled doses of BioThrax to prevent future waste of government funding and resources and that DoD is therefore cancelling its previously announced request for proposal.

Metabolon Wins Anthrax Vaccine Study Contract

Quote: “This type of comprehensive biochemical profiling will help USAMRIID better understand the vaccine’s safety, efficacy, and mechanism of action.”

http://www.wral.com/business/local_tech_wire/biotech/story/2018743/

Research Triangle Park — Metabolon, a provider of research and products centered around biomarkers, has won a contract with the U.S. Army to student the impact of an anthrax vaccine administered to members of the military.

Financial terms were not disclosed. However, a Metabolon spokesperson described the deal as a “large one for us.”Metabolon will work with the U.S. Army Medical Research Institute of Infectious Diseases on the project. Metabolon’s proprietary technology will be part of a regimen to gauge how the body reacts to the AVA anthrax vaccine.

The USARMIID, which is based in Maryland, is part of the U.S. Biological Defense Research Program.

Metabolon has developed patented technology around metabolomics (an approach to identifying biomarkers) that it says will "dramatically impact drug discovery and development processes." Metabolomics is the study of small molecules, such as glucose and cholesterol that are produced by cellular metabolism. The metabolome is the catalog of those molecules in a specific organism.

The technology can be used to identify safer compounds for drug development and thus shorten time to market. Metabolon also says biomarkers can indicate an early presence of a disease.

“This collaboration represents the first large-scale metabolomics study of human subjects given a vaccine,” said Mike Milburn, Metabolon’s chief scientific officer, in a statement. “This type of comprehensive biochemical profiling will help USAMRIID better understand the vaccine’s safety, efficacy, and mechanism of action.”

The contract is further validation of Metabolon’s technology, the company spokesperson said.

“We’re starting to get more and more validation like this not only from the government but also from large pharma and biotech clients as well,” she added.

Metabolon has made several deals related to drug discovery and development as well as bioprocessing in which its technology can optimize cell growth, the spokesperson said.

Just as reporter Mark Benjamin was writing about the squalor and poor treatment of Iraq War vets four years before the Washington Post "discovered" the problems five miles from the their offices last spring, he also addressed "mystery pneumonia" in a series of UPI articles in mid-2003.

There is every indication that these deaths were caused by vaccine experimentation, which the Army apparently stopped after the adverse publicity. The "pneumonia" was identical to an autoimmune condition -- hypersensitivity pneumonitis -- associated with anthrax vaccine in medical journal articles by DoD physicians.

DoD and the Army mounted a cover-up and the blame was placed on Iraqi cigarettes, even though similar cases occurred in non-deployed servicemembers. Only lapdog reporters were invited to participate in a telephone conference with former DoD's ASD (Health Affairs) Dr. William Winkenwerder, and the problem was declared solved.

Emergent won't get anthrax vaccine contract

Emergent BioSolutions Inc. will not get a Department of Defense contract this year for more doses of its Lansing-made anthrax vaccine, officials said today.

The Rockville, Md.-based company said the Defense Department has canceled a request for proposals for more of the vaccine.

Instead, the department will develop a partnership with the Department of Health & Human Services - the other major buyer of the vaccine - to use its stockpile before it expires, company officials said.

Emergent officials previously said they expected the Defense Department to buy 1 million to 3.6 million doses over the next year.

Combined with a recently announced a $448 million deal to supply 18.75 million doses to the Department of Health and Human Services through 2010, that would have brought vaccine production at the former BioPort Corp. facility in north Lansing to near capacity. Emergent has about 325 employes in Lansing.

HHS is stockpiling the vaccine so it could be tapped in the event of a widespread outbreak.

A recent Government Accountability Office report recommended the two departments integrate their vaccine operations to prevent waste.

"We understand the reasons for DoD and HHS to collaborate on an integrated stockpile management program," Fuad El-Hibri, Emergent chairman and chief executive officer, said in a statement. "We also understand that DoD is continuing its active immunization program and thus believe DoD will have future requirements for vaccine supply. We intend to work with both DoD and HHS to better understand how DoD's requirements will be satisfied and the role we will play to address those needs."

Washington, DC...U.S. Senators Robert C. Byrd, D-West Virginia, and Bernie Senders, I-Vermont, applauded the Senate's passage of a $10,000,000 investment in research to combat Gulf War Illness. Byrd and Sanders led the effort to include the funding in the Fiscal Year 2008 Department of Defense Appropriations legislation, which cleared the Senate on November 8th.

"As recent research has further demonstrated, an alarming number of Gulf War veterans continue to suffer serious ailments as a result of exposure to toxic materials during the Persian Gulf War," said Byrd. "It is our moral responsibility to help those who are suffering as a result of illnesses contracted while serving our nation. We can and must do more to find treatments and cures for these serious ailments."

"Over 175,000 veterans are still suffering from a poorly understood set of illnesses related to their service in the first Gulf War," said Sanders. "After years of denial and resistance from the Defense Department and the VA, we are finally beginning to see some promising research that could help our ill service members. This research funding means that we are keeping faith with those who so honorably served our country and who deserve real treatment and a government that lives up toits promise to care for those that wear our uniform."

The complex of symptoms commonly known as "Gulf War Illnesses (GWI)" - widespread pain, cognitive impairment, and persistent fatigue in conjunction with diverse other symptoms and abnormalities - are associated with service in the Southwest Asia theater of operations in the early 1990s during the Persian Gulf War. Byrd and Sanders' efforts are consistent with the Pentagon's historical commitment to findingtreatments and cures for the estimated 175,000 Gulf War veterans affected -- roughly a fourth of those who served.

The provision authorizes $10 million in funding for Gulf War Illnesses research to be conducted by the US Army Medical Research and Materiel Command's Congressionally Directed Medical Research Program (CDMRP) (http://cdmrp.army.mil/aboutus.htm)., which last year initiated a promising pilot program to identify treatments and diagnostic tests for Gulf War illnesses.

The following Veterans Service Organizations support the Byrd/Sanders provision:

* American Legion* Veterans of Foreign Wars* Disabled American Veterans* Paralyzed Veterans of America* Vietnam Veterans of America* AMVETS* Veterans of Modern Warfare

Gulf War Illness Facts

* Three new studies recently released by a team from Boston University, VA, and the Army have added to the compelling body of recent research showing that these illnesses are serious neurological conditions resulting from toxic exposures during the war.

* Ill veterans with five or more symptoms showed a loss of brain mass in MRI scans of areas related to learning and memory, and also performed significantly worse on objective learning and memory tests.

* Veterans exposed to low levels of nerve gas following the destruction of a major Iraqi arms depot at Khamisiyah, Iraq, showed a loss of brain white matter and poor performance on motor coordination tests equivalent to aging 20 years.

* Previous studies have shown that Gulf War veterans have double the rate of ALS found in other veterans, and that veterans potentially exposed at Kamisiyah have double the expected rate of brain cancer deaths.

* Current and future American military forces, as well as civilians, are also at risk of similar exposures and will benefit from the research supported through this funding.

November 1, 2007

Military stockpiling unapproved vaccine - Canada

The Canadian Forces are stockpiling thousands of doses of a smallpox vaccine that has yet to be approved by North American regulators but is supposed to virtually eliminate the sometimes lethal side effects of immunizing against the virus.

It is the latest example in recent years of the Forces buying anti-terrorism medical products that have not been licensed by Health Canada and have to be acquired under the regulator's "special access" program.

Conducting the pricey trials needed for government approval is often financially unfeasible for products geared solely toward the military, National Defence Department officials say. In some instances, it would also be unethical to test countermeasures against nerve gases or other biological and chemical weapons on humans, since the subjects would have to be exposed to the deadly toxin.

In the case of the "modified vaccinia ankara" (MVA) vaccine being ordered by the military, trials are underway and it could be licensed within two years, but the department wants to buy at least 10,000 doses now in case it is needed by troops urgently, said Dr. Francis Souter, in charge of biological warfare countermeasures at the department. Negotiations with the manufacturer are still underway so no cost is available yet.

If a smallpox attack became a real danger, the new product would be administered to the 10% of military personnel thought to be most at risk from vaccine side effects, Dr. Souter said.

"Our hope is that we would never have to use it. It's there only for use after a very careful benefit-risk analysis, threat-risk analysis," he said. "[But] the vaccine does not replicate in the body like the normal one. The side effects associated with it, the safety profile, is much better as a result."

Acquiring the vaccine now despite its lack of licence would seem like a reasonable move, especially since a similar product was actually used experimentally on about 100,000 people in the early 1970s, said Andrew Potter, head of the Vaccine and Infectious Disease Organization at the University of Saskatchewan. "The fact a [version] of it has been in a fairly large number of people ... would probably give a fair level of comfort," he said.

Naturally occurring smallpox, with its 30% death rate, became the first, and to date only, infectious disease to be eradicated worldwide in the early 1970s, thanks to immunization. Samples of the virus still exist, however, at labs in the United States and Russia, raising fears it could get into the hands of terrorists or be used by conventional armies.

Canada and other countries began stockpiling vaccine in the wake of the 9/11 attacks, and the United States has vaccinated thousands of health workers and military personnel since then.

Canadian troops, including those serving in Afghanistan, have not been given smallpox vaccine yet, Dr. Soutter said.

Traditional vaccines introduce a live, replicating virus that builds up an immune response within days, and so can cause problems for people with compromised immune systems or certain other conditions. Because it is pricked into the skin, rather than injected, the vaccination site can also transmit virus to others.

The MVA vaccine is non-replicating, so it seems to pose less threat to the immune compromised, and is injected, meaning there is a smaller chance of transmission.

IDF's medical experiments brought to court

JPost.com IsraelBy JPOST.COM STAFF

Thirty-four IDF soldiers petitioned the High Court of Justice on Thursday in an attempt to put an end to medical experiments the IDF conducts on soldiers.

During their mandatory army service the soldiers were injected a number of times with a substance the IDF claims is an Anthrax antidote. However, they said, the IDF has thus far refused to provide the specific type of medicine used, or the dosages administered. Over 700 soldiers reportedly participated in the experiment after giving their "consent," but each soldier's unique medical condition was allegedly not accounted for by the doctors who conducted the tests, thus causing complications for some of the participants.

The petitioners request that all the relevant data and documentation be released to them.

Doctors for Human Rights also petitioned the High Court against the IDF, saying that in essence, it was easier for the army to conduct experiments on soldiers than on animals. The petitioners, who noted serious problems with the way the tests were conducted, want the Court to order the Defense Minister and Chief IDF medical officer to order a cessation of all further experiments until the matter is properly legislated.

"This situation is highly unacceptable because the soldiers in question are part of a hierarchal system with strict discipline; hence, any consent given [by the soldiers] is suspect and extremely problematic.

"While experimentation on animals requires the approval of a committee not affiliated with the army," the petition continued, "experiments on soldiers are approved within [the IDF's] medical corps.

Petition: Stop medical experimentation on soldiers (Israel)

Physicians for Human Rights says severe failures found in Anthrax vaccine experiment conducted on IDF soldiers between 1999 and 2006. Attorney: These days it is more difficult to experiment on animals than on humans

Physicians for Human Rights (PHR) filed a High Court petition on Thursday calling for an end to medical experiments being carried out on IDF soldiers and the establishment of an external committee to investigate the matter.

A second petition on the matter was filed by a group of soldiers represented by Attorney Boaz Ben-Zur. The soldiers are demanding that they be recognized as casualties of the experiment.

PHR's petition was filed based on the group's findings regarding the "Omer 2" experiment aimed at finding an Anthrax vaccine, which was conducted on some 800 soldiers between 1999 and 2006.

The organization's study found severe failures in the experiment, mainly during registration and the tracking of the soldiers' condition during and after the experiment.

According to PHR, the soldier's were presented with false information regarding the safety of the vaccine, which was developed in the US. In addition, due to the experiment's confidentiality, the soldiers' were not given the opportunity to consult sources outside the army based prior to signing the waver.

"These days it is more difficult to experiment on animals than on humans," said Attorney Michael Spharad, who filed the petition on behalf of PHR. "The existing orders in the IDF make it easier to conduct medical experiments without proper supervision."